Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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No Description
TECHNO-PATH MANUFACTURING LIMITED
UC201X
In Commercial Distribution

  • 05391523440387 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
TECHNO-PATH MANUFACTURING LIMITED
05P80-10
In Commercial Distribution

  • 05391523440073 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
Quantitative determination of fibrinogen in plasma
Siemens Healthcare Diagnostics Products GmbH
10873901
In Commercial Distribution

  • 00842768018503 ()
  • 00630414639741 ()
10873901

  • Fibrinogen assay (factor I) IVD, reagent
Quantitative determination of fibrinogen in plasma
Siemens Healthcare Diagnostics Products GmbH
10873900
In Commercial Distribution

  • 00842768018541 ()
  • 00630414639734 ()
10873900

  • Fibrinogen assay (factor I) IVD, reagent
Siren, 24V, UL Approved
Securitas Healthcare LLC
56108
In Commercial Distribution

  • 00840948101137 ()


  • Nurse call system alarm
Ethernet Switch, 48 Ports, PoE
Securitas Healthcare LLC
56106
In Commercial Distribution

  • 00840948101090 ()


  • Computer network router
Ethernet Switch, 24+2 Ports, PoE
Securitas Healthcare LLC
56105
In Commercial Distribution

  • 00840948101083 ()


  • Computer network router
Arial U Client PC
Securitas Healthcare LLC
56111
In Commercial Distribution

  • 00840948101076 ()


  • Desktop computer
Arial U Server PC
Securitas Healthcare LLC
56110
In Commercial Distribution

  • 00840948101069 ()


  • Network server
CORD, NURSE CALL, 15 FT
Securitas Healthcare LLC
56116
In Commercial Distribution

  • 00840948101052 ()

  • Length: 15 Feet


  • Fixed call button
CORD, NURSE CALL, 7 FT
Securitas Healthcare LLC
56115
In Commercial Distribution

  • 00840948101045 ()

  • Length: 7 Feet


  • Fixed call button
Code Call Station Kit
Securitas Healthcare LLC
CSK-1000-CD
In Commercial Distribution

  • 00840948101038 ()


  • Fixed call button
Arial U Software
Securitas Healthcare LLC
56112
In Commercial Distribution

  • 00840948101021 ()


  • Medical networking interface unit
GW-1000 Gateway
Securitas Healthcare LLC
GW-1000
In Commercial Distribution

  • 00840948101014 ()


  • Medical networking interface unit
Handheld Ultrasound Scanner U Lite Pro with exchangeables probes
SONOSCANNER
PRO
In Commercial Distribution

  • 03701104600291 ()


  • General-purpose ultrasound imaging system
Universal sheath Omnitex U - green - nitrile
OMNIA SRL
30.Z0010.00
In Commercial Distribution

  • 08056646506293 ()
  • 08056646506286 ()


  • Medical equipment/instrument drape, single-use
The medilog®AR is used to record a 3-channel ECG. The recorder is designed for a measuring duration of more than 24 hours and is therefore worn by the patient throughout the day. The preparation for the recording (attachingelectrodes, etc.) is performed by the technician or doctor.
Schiller AG
1A.306010
In Commercial Distribution

  • 07613365003765 ()
  • 07613365003697 ()
1A.306010

  • Electrocardiographic ambulatory recorder
Dual-curing universal adhesive. DCA Dual cure activator.
VOCO GmbH
1578
In Commercial Distribution

  • E22115781 ()
1578

  • Dentine bonding agent/set
Dual-curing universal adhesive in 5ml bottles
VOCO GmbH
1577
In Commercial Distribution

  • E22115771 ()
1577

  • Dentine bonding agent/set
Dual-curing universal adhesive.
VOCO GmbH
1576
In Commercial Distribution

  • E22115761 ()
1576

  • Dentine bonding agent/set
Dual-curing universal adhesive.
VOCO GmbH
1574
In Commercial Distribution

  • E22115741 ()
  • E22115740 ()
1574

  • Dentine bonding agent/set
Dual-curing universal adhesive.
VOCO GmbH
1572
In Commercial Distribution

  • E22115721 ()
  • E22115720 ()
1572

  • Dentine bonding agent/set
Dual-curing universal adhesive.
VOCO GmbH
1571
In Commercial Distribution

  • E22115711 ()
  • E22115710 ()
1571

  • Dentine bonding agent/set
Handheld Ultrasound Scanner U Lite Pro with exchangeables probes
SONOSCANNER
PRO
Not in Commercial Distribution

  • 37011046002914 ()


  • General-purpose ultrasound imaging system
physIQ Medical Device Data System Android App
PHYSIQ, INC
3.4 (Edison)
In Commercial Distribution

  • 00860004366218 ()


  • Electrocardiography telemetric monitoring system
Jacoti Listen App 2.X
Jacoti
Jacoti Listen App 2.X
In Commercial Distribution

  • 05407004250014 ()


  • Air-conduction hearing aid, wearable case
prolaio medical device data system mobile application
Prolaio, Inc.
DP-22-06
In Commercial Distribution

  • 00850071330007 ()


  • Electrocardiography monitoring system receiver
SW, EXE, Lifeline Response Smart Phone Application, Google
Lifeline Systems Company
300000161331
Not in Commercial Distribution

  • 00884838082137 ()
mSafe

  • Vulnerable patient home alert system
SW, EXE, Lifeline Response Smart Phone Application, Apple
Lifeline Systems Company
300000161311
Not in Commercial Distribution

  • 00884838082120 ()
mSafe

  • Vulnerable patient home alert system
No Description
Get-Grin Inc.
Initial Release
In Commercial Distribution

  • D962GGAR0003 ()


  • Radiological PACS software
No Description
Get-Grin Inc.
W Version
In Commercial Distribution

  • D962GGAW0002 ()


  • Radiological PACS software
No Description
Ventric Health
VA 1.0
In Commercial Distribution

  • 00850044849024 ()


  • Cardiac mapping system application software
Windows PC Application for use with Eko products.
Eko Devices, Inc.
1.2.4
In Commercial Distribution

  • 00863609000358 ()


  • Medical equipment clinical data interfacing software
This is an application intended to be used by neurologists who are monitoring or reviewing EEGs. It is part of a larger system provided by Persyst.
Persyst Development Corp
App for Web
Not in Commercial Distribution

  • 00869732000142 ()


  • Bioelectrical signal analysis software
The Persyst Mobile App is a software application that can be executed on a mobile platform. It is capable of displaying the original EEG data, and quantitative analysis of EEG data generated by the Persyst EEG Review and Analysis Software. This Mobile App is intended to be used by qualified medical practitioners who will exercise professional judgement in using the information.
Persyst Development Corp
Persyst Mobile App
In Commercial Distribution

  • 00869732000135 ()


  • Bioelectrical signal analysis software
No Description
Garmin International, Inc.
1.x
In Commercial Distribution

  • 00860009117716 ()


  • Cardiopulmonary physiological parameter analysis software
No Description
Garmin International, Inc.
1.x
In Commercial Distribution

  • 00860009117709 ()


  • Cardiopulmonary physiological parameter analysis software
MapRT is used to assist treatment planning whereby the patient surface and positioning devices captured at simulation can be modelled against the treatment devices, such that any potential collisions can be predicted.
VISION RT LIMITED
MapRT Web app 1.1
In Commercial Distribution

  • 05056190500887 ()
MapRT Web app

  • Radiation therapy software
MapRT is used to assist treatment planning whereby the patient surface and positioning devices captured at simulation can be modelled against the treatment devices, such that any potential collisions can be predicted.
VISION RT LIMITED
MapRT Web app
In Commercial Distribution

  • 05056190500771 ()
MapRT Web app

  • Radiation therapy software
myCordella Patient App is a component of the myCordella Patient Kit. myCordella Patient App is an intuitive, user-friendly software that assists patients with obtaining vital sign measurements. • Collects & securely transmits daily health information to clinicians • Facilitates review of past measurements • Allows secure communication between patient and clinician
Endotronix, Inc.
100256-02
In Commercial Distribution

  • 00850008997037 ()


  • Bedside monitor remote-viewing software, physiological parameter
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